MAUDE Adverse Event Report: AESCULAP AG TROCAR SLEEVE 5/110MM THREADED WITH TAP; REUSABLE TROCARS

Model Number EK016R

Device Problem Material Fragmentation (1261)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/15/2019

Event Type  malfunction  

Manufacturer Narrative

Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.

Event Description

It was reported that there was an issue with the product trocar sleeve 5/110mm threaded with tap.During a diagnostic 'laparascopy' (pancreas) there was friction of the "mic" outer tube from a competitor product, which was used in combination with the trocar sleeve.No parts remained in the abdominal cavity.There was no patient harm.Additional information was not available.The malfunction is filed under aag reference (b)(4).Associated medwatch-reports: 9610612-2019-00809.

Manufacturer Narrative

Manufacturing site evaluation: 2 trocars and one competitor instrument were available for investigation decontaminated.Internal notification number: (b)(4).Device reference code ek016r ((b)(4)); device name trocar sleeve 5/110mm threaded with tap; serial number n/a; batch number 52387724 udi device identifier (b)(4); udi production identifier unknown; basic udi-di n/a; unit of use udi-di (b)(4); manufacturing date 24.11.2017.Reference code ek016r ((b)(4)); device name trocar sleeve 5/110mm threaded with tap; serial number n/a; batch number unknown; udi device identifier (b)(4); udi production identifier unknown; basic udi-di n/a; unit of use udi-di (b)(4); manufacturing date unknown; investigation - failure description - all provided trocars are in an used condition.The insulation of the instrument is cut beginning from the distal end to proximal end.Vigilance investigator carried out the pictorial documentation visually1 and microscopically2.At the distal end of the trocars, slightly sharp edges can be recognized most likely caused by wear and tear, e.G.Caused by movement of instruments during handling.The insulation of the instrument is peeled off partially.Scratches and damages can be found all over the surface of the insulation.Nevertheless, it is not comprehensible how the insulation was damaged this way.Even under high pressure during a functional test with the provided components, a peel off of the insulation could not be confirmed.Furthermore, the cut is beginning from the distal end to proximal end.A peel off of the insulation caused by the distal end of the trocar would start the other way, from proximal to distal end.Batch history review - the device quality and manufacturing history records have been checked for the available lot number (52387724) and found to be according to our specifications valid at the time of production.One similar incidents have been filed with products from this batch.Conclusion and root cause - based on the information available as well as a result of our investigation the root cause of the failure is most probably related to an insufficient usage.Rationale - refer to investigation.Corrective action - according to sop sa-de13-m-4-2-01-000-0 (corrective action and preventive action) a capa regarding the surface of trocars (#59714) has already been initiated.

• Brand Name: TROCAR SLEEVE 5/110MM THREADED WITH TAP
• Type of Device: REUSABLE TROCARS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 9418672
• MDR Text Key: 179256482
• Report Number: 9610612-2019-00808
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• PMA/PMN Number: K101937
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 12/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EK016R
• Device Catalogue Number: EK016R
• Device Lot Number: 52387724
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2019
• Date Manufacturer Received: 12/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1